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MSZ EN IEC 60601-2-35:2021

Dokumentumazonosító

177852

Cím

Gyógyászati villamos készülékek. 2-35. rész: Gyógyászati használatú melegítőtakarók, -párnák és -matracok fűtőkészülékeinek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-35:2020)

Angol cím

Medical electrical equipment. Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 60601-2-35:2020)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of 60601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document does not apply to: – HEATING DEVICES intended for physiotherapy; – INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2; – INFANT INCUBATORS; for information, see IEC 60601-2-19 [2]; – INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3]; – cooling devices. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements, which minimize HAZARDS to PATIENTS, and OPERATORS for HEATING DEVICES using BLANKETS, PADS or MATTRESSES and intended for heating in medical use and to specify tests for demonstrating compliance with these requirements. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, and IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 apply as modified in Articles 202, 208 and 210 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published. Túl hosszú scope

ICS

11.040.01 Orvostechnikai berendezések általában

11.140 Kórházi berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-12-01

Forrás

idt IEC 60601-2-35:2020; idt EN IEC 60601-2-35:2021

Előd

MSZ EN 80601-2-35:2010, MSZ EN 80601-2-35:2009/A11:2012, MSZ EN 80601-2-35:2009/A1:2017

Utód

Módosítás

MSZ EN IEC 60601-2-35:2021/A1:2024

Kiegészítő információk

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